FDA Medical Device Recalls (openFDA)
Remote Diagnostic Technologies Ltd.: Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
- Recall number
- Z-0861-2022
- Recalling firm
- Remote Diagnostic Technologies Ltd.
- Product
- Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
- Status
- Terminated
- Initiated
- 2022-01-28
- Posted
- not on file
- Terminated
- 2024-07-25
- Reason
- Distribution of Defibrillators that are not approved or cleared for distribution US Market.
- Root cause
- No Marketing Application
- Action
- On January 31, 2022 , Remote Diagnostic initiated notified customer about the recall device via email. Remote Diagnostic issued a "Urgent Medical Device Recall" notification on February 18, 2022 to affected consignees. In addition, to informing consignees about the recalled product, the Remote Diagnostic asked consignees to take the following actions: 1. Arrangements have been made by Philips SPS (Spare Parts Supply Chain) to have the devices returned to Philips and for the devices to be replaced with the correct model of devices, i.e. Tempus LS-Manual (Part Number 00-3020) 2. If you need any further information or support concerning this issue, please contact your local Philips representative - Email: RDT.Recall.Response@philips.com, - Phone: 1 (800) 7222-9377/ +44 (0) 1256 362400 3. Please complete and return this form to Philips promptly upon receipt and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Recall Letter, understanding of this issue, and required action to be taken.
- Quantity
- 2
- Distribution
- US Nationwide distribution in the states of IL and KS.
- Lot, serial or model codes
- Device Serial Numbers 7021.002073 and 7021.002074
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LDD
- Firm FEI
- 3003832357
- Firm city
- Basingstoke
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28